AMxTek LLC is a combination product medical device consulting company. A combination product is a medical device that is part device and part drug or biologic. The CDRH branch of the FDA regulates such products, providing the product’s Primary Mode of Action [PMOA] remains that of a medical device. Consulting Services: AMxTek assists corporate clients in an array of front-end business development, technology due diligence, product development and regulatory affairs consulting activities associated with combination product medical devices. When business decisions need to be made regarding investment, technology, opportunity-cost and commercialization strategy, AMxTek provides critical third-party objectivity and expertise regarding combination product medical device business planning and implementation. IP Development: AMxTek LLC also develops Intellectual Property [IP] for business development opportunities and licensing, when and where technology and novelty can be brought to bear on unmet clinical needs. AMxTek concept development and IP secures early proprietary combination product market positions, creating discontinuities in traditional medical market segments, leveraging the unique utility and value proposition of such hybrid products. This affords AMxTek IP licensees: i) proprietary combination products; ii) lower commercialization risk; and iii) reduced time to market. AMxTek LLC currently provides combination product medical device Consulting Services and IP Development in the following fields: ➢ Antimicrobial Medical Devices ➢ Osteogenic Implants and Devices